The aim of Medical Devices Regulation 2017/745 (MDR) revision is to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.
Although the MDR took effect in May 2021, it is providing the industry with a soft transition period from the Medical Device Directive. This means that products already certified under the previous MDD directive, can be marketed in the EU until 2027 / 2028 giving a few conditions, like no significant design specification change for example.
To support manufacturers in their transition to MDR and to place new devices on the EU market, we developed a plan to analyze the gaps and assess the required actions to achieve compliance with MDR.
Our Eight-Steps plan includes MDR analysis, impact assessment and implementation of the processes:
|MDR Gap Analysis
|STEP 1: Understanding MDR requirements and performing gap assessment
|Perform impact assessment of the gap
|STEP 2: Impact assessment of the gap covering both QMS and Product
|STEP 3: Prepare Master remediation plan including budget and resources planning
|STEP 4: Prepare detailed remediation and implementation plan per company division (R&D, manufacturing, purchasing, testing, etc.)
|Implement processes to demonstrate compliance with MDR
|STEP 5: Company regulatory training on MDR implications
|STEP 6: Compliance effort
|STEP 7: Specific trainings for each division
|STEP 8: Effectiveness evaluation by audits
With this plan, we can determine the priorities for initiating the critical action items on time leading the extensive effort to be manageable and attainable.
STEP 1: Comprehension of the MDR requirements at the company level
We are starting by reviewing the company quality system, to conduct a comprehensive gap assessment and identify the required steps to achieve compliance with MDR, considering the type of device and its regulatory status (legacy devices, or devices never placed on the EU market).
During this step, we are reviewing company procedures to assess compliance of the whole quality system with the MDR (and CFR 820 and other when relevant) requirements.
Impact assessment Phase
STEP 2: Perform impact of the gap assessment covering both the QMS and the Product. This impact assessment helps the company to capture and evaluate the impacts of the MDR on the company quality system (QMS) and product performance. The impact assessment includes adjustment of the company Standard Operating Procedures (SOP) to comply with MDR requirements (revision of existing SOP or creation of new SOP) and conducting internal audit per company divisions. This includes the design processes, QMS main processes and clinical processes.
During this step, we are reviewing the technical documentation, to understand and map the efforts and resources needed to prepare a good and appropriate technical documentation.
STEP 3: Prepare Master remediation plan including resources planning
Next step, once all gaps are identified and mapped, we are generating a master remediation and resource planning with the required resources (subcontractors, employees, out-sourced consultation), budget planning and estimated timeline.
STEP 4: Prepare detailed remediation and implementation plan per division
Based on the master remediation plan, each division within the company can prepare a detailed implementation plan per activity and determine the priorities according to specific remedy.
STEP 5: Company regulatory training on MDR implications
We will prepare and execute an annual training program designated for MDR implementation. This plan will include at least the following subjects:
- Design control
- Risk management
- Device classification and technical documentation
- Clinical evaluation
- Post-Market Surveillance (PMS)
- Economic operators
STEP 6: Compliance effort
During this step, each division will carry out the necessary activities in accordance with the master plan for implementation. The remediation will be divided into two:
- Efforts to remediate QMS gaps.
- Remediate and generate the Technical Documentation (TD)
STEP 7: Specific trainings for each division
At this step, training sessions on MDR implications per division for new procedures and modified processes are conducted.
STEP 8: Effectiveness evaluation by audits
Finally, at the end of this process, internal audits will allow a complete evaluation of the implementation and effectiveness of the plan.
 According to MDR 2017/745 (as amended by regulation 2020/561 and regulation 2023/607) Article 120 paragraph 2-6.